Katherine M. Layman

Katherine M. Layman's practice includes compliance and regulatory advice, often in connection with ongoing litigation or transactions, for a variety of health care providers, including hospitals and hospital systems, long term care providers, hospices, mental health providers, physicians and physician groups, clinical laboratories, suppliers, pharmacies and medical device manufacturers.

Kate handles a wide range of health law issues. She has written and spoken extensively about HIPAA and privacy issues for providers and for business associates, and provides compliance counsel to a variety of firm clients on privacy, security and the developing area of cybertechnology. She counsels long term care providers, including nursing homes, assisted living facilities, and continuing care communities, on survey, licensure and other compliance issues. For other clients, she provides regulatory, licensure, and fraud and abuse guidance, with a particular focus on the operation of Medicare, Medicaid and other third-party reimbursement programs in the context of the client's business. She has worked with firm clients in becoming compliant with the Medicare Secondary Payer law and its reporting requirements, has assisted in resolving settlement agreements involving MSP issues and has spoken frequently about the MSP law.

Kate earned her Bachelor of Arts, with distinction, from the University of Michigan in 1971. She earned her law degree, cum laude, from Temple University School of Law in 1993, where she served on the Temple Law Review. Upon graduation from law school, she served as a law clerk to the Honorable James M. Kelly of the U.S. District Court for the Eastern District of Pennsylvania.

Experience

Represented Mid-Atlantic Health Care in Baltimore in a $75 million acquisition of five Philadelphia nursing homes.

Represented the National Association of Chain Drug Stores on numerous projects, including a comprehensive analysis of the statutes, regulations and case law governing reimbursement requirements and rate reductions by State Medicaid programs and in the Massachusetts District Court AWP rebate and pricing litigation.

As part of admission into a nursing home, a facility typically requires prospective residents to agree to binding arbitration. Arbitrating disputes generally allows nursing facilities to handle disputes without incurring the onerous costs – both of time and money - associated with litigation....

On January 25, 2013, the Office of Civil Rights (OCR) of the Department of Health & Human Services (HHS) published the long-awaited omnibus final regulation governing health data privacy, security and enforcement (Omnibus Rule).[i] The Omnibus Rule is a group of regulations that finalizes four...

On January 25, 2013, the Office of Civil Rights (OCR) of the Department of Health & Human Services (HHS) published the long-awaited omnibus final regulation governing health data privacy, security and enforcement (Omnibus Rule). The Omnibus Rule is a group of regulations that finalizes four sets of proposed or interim final rules, including changes to the Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Rules mandated by the Health Information Technology for Economic and Clinical Health (HITECH) Act and proposed in 2010; changes to the interim final breach notification rule; modifications to the interim final enforcement rule; and implementation of changes to the Genetic Information Nondiscrimination Act of 2008 (GINA). The Omnibus Rule goes into effect on March 26, 2013, and compliance is required by September 23, 2013. As expected, the Omnibus Rule did not finalize the May 31, 2011 proposed regulation regarding accounting for disclosures.

Since the implementation of the privacy and security regulations of the Health Insurance Portability and Accountability Act (“HIPAA”) in 2003 and 2005 respectively, business associates (“BAs”) – those entities that perform services for or on behalf of covered entities – had been a weak link in the...

The Medicare Secondary Payer Act - CMS Provides Initial Guidance on Medicare Set Asides in Liability Settlements - Health Law Alert! - On September 30, 2011, CMS, for the first time, issued guidance on the use of Liability Medicare Set-Aside Arrangements (LMSAs) related to liability insurance settlements and judgments (the Guidance)¹. The absence of any formal direction from CMS on the handling of LMSAs has been a significant hindrance in settlement discussions, and even though this Guidance is relatively limited, it is nonetheless helpful

CMS Delays Section 111 Reporting for Liability Insurers - Health Law Alert! - the Centers for Medicare & Medicaid Services (CMS) announced a one-year delay in the implementation of certain reporting obligations under Section 111 of the Medicare, Medicaid, and SCHIP Extension Act of 2007 for claims involving liability insurers (including self-insured entities). Claims involving workers’ compensation and no-fault insurance, however, must be reported as scheduled in the first calendar quarter of 2011. The net result is a two-tiered implementation timeline.

The Medicare Secondary Payer Act and Its Impact on Litigation - The Legal Intelligencer - The Medicare Secondary Payer Act (MSP Act) was first enacted in 1980; however, it is the recent Section 111 reporting requirements (that become effective Jan. 1, 2011, for settlements entered into on or after Oct. 1, 2010) that have brought that statute to the forefront of personal injury and insurance defense litigation. Because liability settlements that include Medicare beneficiaries now have to be reported to the

The Medicare Secondary Payer Act and its Impact on Litigation - The Legal Intelligencer Annual Health Law Supplement - The Medicare Secondary Payer Act (the “MSP Act”) was first enacted in 1980; however, it is the recent Section 111 reporting requirements (that become effective January 1, 2011 for settlements entered into on or after October 1, 2010) that have brought that statute to the forefront of personal injury and insurance defense litigation. Because liability settlements that include Medicare beneficiaries now have to be...

FTC Again Delays Enforcement of Red Flags Rule - Health Law Alert! - On July 29, 2009, just three days before the effective date of the "Red Flags Rule" (the "Rule"), the Federal Trade Commission ("FTC") announced that it would again delay enforcement of Rule from August 1, 2009 until November 1, 2009. The FTC delayed enforcement to allow it to further educate small business and health care providers about the Rule and what they need to do to comply with its requirements

Red Flags Rule Enforcement Delayed...Again - Health Law Alert! - On April 30, 2009, the eve of the effective date of the “Red Flags Rule,” the Federal Trade Commission (FTC) announced that it would again delay enforcement of the Rule until August 1, 2009 in order to allow organizations more time to develop and implement written identity theft
prevention programs. The FTC also announced plans to release a template to help entities that have a low risk of identity theft, such as businesses that know their customers personally, comply with the law

The American Recovery and Reinvestment Act of 2009: Sweeping Changes to HIPAA Put Business Associates in the Spotlight - Health Law Alert! - On February 17, 2009, President Obama signed into law the Health Information Technology for Economic and Clinical Health Act (“HITECH” or the “Act”), as part of the American Recovery and Reinvestment Act of 2009. The Act made
sweeping changes to the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) and the Privacy and Security Rules promulgated under HIPAA. This Alert focuses
primarily on Subtitle D of HITECH, which includes important

Patent-Tailored Medicine, Part Two: Personalized Medicine and the Legal Landscape - Journal of Health & Life Sciences Law - In Part One, the authors addressed the relevance of genetic information, and how race and genetics have affected and may impact the development of medicines, pharmacogenomics, and personalized medicine in the United States. Part Two examines current and proposed federal and state laws and regulations intended to protect individuals from the misuse of genetic information, including uses that discriminate based on genetic...

Internet Prescribing: It’s Fast and Easy, But Is It Legal? - ANDREWS LITIGATION REPORTER - The Internet pharmacy industry is booming and apparently will only get bigger, unless, that is, the federal government decides that prescriptions written without a face-to-face meeting between the physician and patient are invalid. Given its recent enforcement efforts, the government may well be headed in that direction.